Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:48 AM
Ignite Modification Date: 2025-12-26 @ 3:49 AM
NCT ID: NCT01722318
Description: A total of 428 patients were randomized and received at least one dose of medication except for one patient in the 0.3 mg plecanatide group. Therefore, a total of 427 patients were included in the safety population for adverse events reporting.
Frequency Threshold: 2
Time Frame: 12 weeks
Study: NCT01722318
Study Brief: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Plecanatide 0.3mg Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks Plecanatide None None 1 85 18 85 View
Plecanatide 1.0mg Plecanatide 1.0mg one tablet by mouth daily for 12 weeks Plecanatide None None 0 85 29 85 View
Plecanatide 3.0mg Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks Plecanatide None None 1 86 19 86 View
Plecanatide 9.0mg Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks Plecanatide None None 2 85 31 85 View
Placebo Placebo, one tablet by mouth daily for 12 weeks Placebo None None 0 86 12 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (14.0) View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (14.0) View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (14.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (14.0) View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (14.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (14.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.0) View